Maneuverable surgical stapler

ABSTRACT

Embodiments include a surgical device and a method. An embodiment of the surgical instrument includes at least one grasping jaw, the at least one grasping jaw being adapted to deliver surgical staples by a force generated from a force generator mechanism that is contained within the at least one grasping jaw or is in a proximity to the at least one grasping jaw. Another embodiment includes at least one grasping jaw, at least one delivery mechanism adapted to deliver surgical fasteners, the delivery mechanism being located in a proximity to or contained within the at least one grasping jaw, the surgical fasteners containing at least one shape-transforming material, at least one sensor, at least one chemical tissue sealant and at least one cutter. A method includes: grasping a body tissue with at least one grasping jaw, adjusting a configuration of the grasping in response to a signal or a datum or an image, and releasing a surgical staple/fastener in response to the signal, datum or image.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is related to and claims the benefit of theearliest available effective filing date from the following listedapplication (the “Related Applications”) (e.g., claims earliestavailable priority dates for other than provisional patent applicationsor claims benefits under 35 USC §119(e) for provisional patentapplications, for any and all parent, grandparent, great-grandparent,etc. applications of the Related Application(s)).

RELATED APPLICATIONS

For purposes of the United States Patent Office (USPTO) extra-statutoryrequirements, the present application is a CONTINUATION application ofU.S. patent application Ser. No. 11/894,044 titled MANEUVERABLE SURGICALSTAPLER naming Edward S. Boyden, Roderick A. Hyde, Muriel Y. Ishikawa,Eric C. Leuthardt, Nathan P. Myhrvold, Dennis J. Rivet, Michael A.Smith, Clarence T. Tegreene, Thomas A. Weaver, Charles Whitmer, LowellL. Wood, Jr. and Victoria Y. H. Wood as inventors, filed 17 Aug. 2007,now U.S. Pat. No. 7,823,761, which is a continuation-in-part of U.S.patent application Ser. No. 11/804,219, filed on 16 May 2007, now U.S.Pat. No. 7,832,611.

The United States Patent Office (USPTO) has published a notice to theeffect that the USPTO's computer programs require that patent applicantsreference both a serial number and indicate whether an application is acontinuation or continuation-in-part. Stephen G. Kunin, Benefit ofPrior-Filed Application, USPTO Official Gazette Mar. 18, 2003, availableat http://www.uspto.gov/web/offices/com/sol/og/2003/week11/patbene.htm.The present Applicant Entity (hereinafter “Applicant”) has providedabove a specific reference to the application(s) from which priority isbeing claimed as recited by statute. Applicant understands that thestatute is unambiguous in its specific reference language and does notrequire either a serial number or any characterization, such as“continuation” or “continuation-in-part,” for claiming priority to U.S.patent applications. Notwithstanding the foregoing, Applicantunderstands that the USPTO's computer programs have certain data entryrequirements, and hence Applicant is designating the present applicationas a continuation-in-part of its parent applications as set forth above,but expressly points out that such designations are not to be construedin any way as any type of commentary and/or admission as to whether ornot the present application contains any new matter in addition to thematter of its parent application(s).

All subject matter of the Related Applications and of any and allparent, grandparent, great-grandparent, etc. applications of the RelatedApplications is incorporated herein by reference to the extent suchsubject matter is not inconsistent herewith.

TECHNICAL FIELD

The present application relates, in general, to devices, methods orsystems for treatment or management of disease, disorders, orconditions.

SUMMARY

An embodiment of a surgical instrument comprises a surgical stapler. Inone embodiment, the surgical stapler comprises at least one graspingjaw, the at least one grasping jaw being adapted to deliver surgicalstaples by a force generated from a force generator mechanism that iscontained within the at least one grasping jaw or is in a proximity tothe at least one grasping jaw. In a further embodiment, the at least onegrasping jaw is configured to movably operate in an opposing manner withrespect to at least one other grasping jaw. In another embodiment, atleast one grasping jaw is configured to operably mate with at least oneother grasping jaw. In yet another embodiment, at least one grasping jawis configured to serve as an anvil for forming an interaction surfacebetween at least one surgical staple and bodily tissues, the formingbeing facilitated by reversible mating and unmating of the anvil with anopposite grasping jaw. Furthermore, at least one grasping jaw may forman annular grasp around a body tissue.

In one embodiment, the surgical stapler has a force generated from aforce generator mechanism is communicated to a medium resulting in therelease of at least one surgical staple. The force may further result indelivery of one or more linear rows of surgical staples. The forcegenerating mechanism may further include at least one of a pressurizedgas canister/cartridge, a spring, a lever, an explosive charge, apiezoelectric actuator, an electric motor, an electroactive polymer or asolenoid.

In another embodiment, the surgical stapler comprises at least oneenergy module. The energy module may include at least one of a battery,a capacitor, a fuel cell, a mechanical energy storage device, or a fluidenergy storage device. Furthermore, the energy module may be located inproximity to at least one grasping jaw or within at least one graspingjaw. In a further embodiment, the energy module transmits energy througha medium containing at least one of the following: a wire, a tube, anoptical fiber or a waveguide. Alternatively, the energy module transmitsenergy through a wireless device.

In one embodiment, the surgical stapler may include a flexuallydeformable and steerable shaft connected to at least one grasping jaw.The shaft may contain at least one shape-transforming material, whichmay include a shape memory alloy. In other embodiments, the shape memoryalloy includes at least one of the following components: titanium,nickel, zinc, copper, aluminum, cadmium, platinum, iron, manganese,cobalt, gallium or tungsten. The shape memory alloy may also includeNitinol™ or an electro-active polymer. Furthermore, at least oneshape-transforming material includes at least one mechanicallyreconfigurable material. In an embodiment, the surgical instrumentfurther comprises at least one sensor. At least one sensor may bedisposed in at least one grasping jaw of the surgical instrument.Alternatively, the at least one sensor may be disposed in proximity toat least one grasping jaw. In one embodiment, the at least one sensorincludes an image-acquisition device. The image-acquisition device mayinclude at least one of the following: a camera, a charge coupleddevice, an X-ray receiver, an acoustic energy receiver, a photodetector,an electromagnetic energy receiver or an imaging device.

In an embodiment of the surgical stapler, the sensor includes anillumination device that is operably coupled to at least oneimage-acquisition device. In a further embodiment, the image-acquisitiondevice is wirelessly coupled to at least one visual display. The atleast one sensor may include a data-transmission device. In yet anotherembodiment, at least one sensor includes a proximity detector. Theproximity detector may be adapted to detect proximity of a biologicaltissue to the surgical instrument. In an embodiment, the proximitydetector includes an electromagnetic energy emitter or anelectromagnetic energy receiver. In yet another embodiment, proximitydetector includes an acoustic energy emitter and an acoustic energyreceiver. In another embodiment, the proximity detector includes a pointsource emitter or a source illuminator. In an alternative embodiment,point source emitter or a source illuminator is operably coupled to atleast one image acquisition device. The point source emitter or a sourceilluminator may include at least one of an ultrasonic source, anacoustic source, a visible source, an ultraviolet source, a gamma raysource, an X-ray source or an infrared source. Furthermore, the pointsource or source illuminator may be operably configured within agrasping jaw of the surgical instrument. In one embodiment, theproximity detector includes a communication medium for communicationwith at least one image display. In another embodiment, the proximitydetector may also include at least one image-transmission device or onedata-transmission device. In yet another embodiment, the proximitydetector is wirelessly coupled to at least one image display.

In an embodiment, at least one sensor provides a feedback signal, adatum or an image to a human or robotic user. Furthermore, at least onesensor provides a force feedback signal to a force generator mechanism.Another embodiment provides at least one sensor that communicates asignal, a datum or an image regarding status of the number of staples inthe surgical instrument. Furthermore, at least one sensor may provide asignal, a datum or an image regarding functional status or malfunctionalstatus of the surgical instrument.

In another embodiment, the surgical instrument further comprises atleast one cutter. In yet another embodiment the cutter may be an opticalcutter or a laser-mediated cutting device or an electro-thermal cuttingdevice. In a further embodiment, at least one cutter may include ablade, a knife or an edge. An embodiment provides that at least onecutter is operably coupled to at least one grasping jaw.

The surgical instrument may be further configured to deliver a chemicaltissue sealant. The chemical tissue sealant may be housed inside atleast one grasping jaw. An embodiment provides that the chemical tissuesealant be a biocompatible or a biodegradable sealant. Furthermore, thechemical sealant is delivered in a proximity to at least one staple, andis preferably delivered between at least two adjacent layers of bodytissue. In some embodiments, surgical staples may include fasteners,pins or ties.

An embodiment of the surgical instrument provides at least one graspingjaw. In another embodiment, the at least one grasping jaw comprises adelivery mechanism adapted to deliver surgical fasteners. In anembodiment, the delivery mechanism may be located in a proximity to atleast one grasping jaw. In an alternative embodiment, the deliverymechanism may be contained within at least one grasping jaw.Furthermore, the surgical fasteners may contain at least oneshape-transforming material. The surgical instrument may optionallyinclude at least one sensor. In some embodiments, the at least onegrasping jaw is configured to movably operate in an opposing manner withrespect to at least one other grasping jaw. In an alternativeembodiment, at least one grasping jaw is configured to operably matewith at least one other grasping jaw. In yet another embodiment, atleast one grasping jaw is configured to serve as an anvil for forming aninteraction surface between at least one surgical fastener and bodilytissues, the forming being facilitated by reversible mating and unmatingof the anvil with an opposite grasping jaw. Moreover, at least onegrasping jaw may form an annular grasp around a body tissue. In oneembodiment, the delivery mechanism utilizes a force generated from aforce generator mechanism contained within or in a proximity to at leastone grasping jaw. Furthermore, the delivery mechanism results indelivery of one or more linear rows of surgical fasteners. An embodimentprovides that the force generated from the force generator mechanismincludes at least one of a pressurized gas canister/cartridge, a spring,a lever, an explosive charge, a piezoelectric actuator, an electricmotor, an electroactive polymer, a hydraulic force, a pneumatic force,or a solenoid.

An aspect of the invention includes a surgical instrument comprising aflexually deformable and steerable shaft operably connected to at leastone grasping jaw having a force generator mechanism that is containedwithin the at least one grasping jaw or is in a proximity to the atleast one grasping jaw. The surgical instrument may further comprise ofat least one grasping jaw that is independently maneuverable from anattached shaft or sheath. Additionally or alternatively, the flexuallydeformable and steerable shaft may be enclosed in a bendable andsteerable tube or a sheath. Furthermore, in an embodiment, the flexuallydeformable and steerable shaft may be controllably deformable andsteerable to permit a high degree of maneuverability of the surgicalinstrument. Alternatively or additionally, the flexually deformable andsteerable shaft may contain at least one shape-transforming material. Inone embodiment, the at least one shape-transforming material contains ashape memory alloy. In another embodiment, the shape memory alloyincludes at least one of titanium, nickel, zinc, copper, aluminum,cadmium, platinum, iron, manganese, cobalt, gallium or tungsten.Additionally or alternatively, the at least one shape-transformingmaterial may be preconfigured to a particular application and body partgeometry. Furthermore, the at least one shape-transforming material mayassume a different shape compared to an original preconfigured shapeupon insertion of the surgical instrument into a body to conform to anoptimal orientation. The flexually deformable and steerable shaft mayinclude the shape memory alloy Nitinol™. In yet another embodiment, theflexually deformable and steerable shaft may contain at least oneshape-transforming material that includes an electro-active polymer. Instill another embodiment, the at least one shape-transforming materialincludes at least one mechanically reconfigurable material. In oneembodiment, the flexually deformable and steerable shaft may becontrollably deformable and steerable to permit a high degree ofmaneuverability of the surgical instrument that includes controllabledeformation of the shaft that is mediated by at least one of atemperature profile, a pressure profile, an electrical circuitry, amagnetic profile, an acoustic wave profile or an electro-magneticradiation profile. The maneuverability of the surgical instrumentincludes maneuverability around anatomical corners or difficult-to-reachanatomical body parts that are normally inaccessible on a straighttrajectory. In an embodiment, the flexually deformable and steerableshaft that is being controllably deformable to permit a high degree ofmaneuverability of the surgical instrument includes bending the shaft inreal time to navigate within a body space. In still another embodiment,the flexually deformable and steerable shaft returns to an originalshape or configuration for easy removal from a body. In yet anotherembodiment, the surgical instrument may include at least one graspingjaw having a proximity detector. The proximity detector may be adaptedto detect whether a biological tissue is within grasping distance of thegrasping jaw. Furthermore, the proximity detector may also be adapted todetect whether a biological tissue is fully grasped by the grasping jaw.In an embodiment, the proximity detector is operably configured toassess whether an entire bodily organ or a portion of a bodily organ isfully or partly grasped within said grasping jaw. Alternatively oradditionally, the grasping jaw may be fully redeployable following atleast one grasp-release cycle in a grasping operation of a biologicaltissue. Additionally or alternately, the surgical instrument may be asurgical stapler that is adapted to deliver biodegradable ornon-biodegradable staples, fasteners, pins or ties.

An aspect of the invention includes a surgical instrument comprising atleast one grasping jaw; a force receiver adapted to receive manual forcefrom a user; and an actuation mechanism responsive to the manual forceto produce a jaw-laden force without mechanical coupling of the manualforce to the grasping jaw. In an embodiment, the surgical instrumentfurther includes the force receiver includes at least one sensor. In yetanother embodiment, the at least one sensor is operably coupled to theactuation mechanism. Furthermore, the at least one sensor receives asignal from the actuation mechanism through a wireless medium. Inanother embodiment, the surgical instrument includes the at least onesensor that transmits a signal to the actuation mechanism through awireless medium. In still another embodiment, the surgical instrumentincludes a user-activated sensory-device, tactile-device oraudio-sensitive device that transmits a signal to the force receiver.The user-activated sensory, tactile or audio-sensitive device may be amanual trigger, a pushbutton, a latch, a lever, a voice activateddevice, a touch-sensitive device, a breath-activated device etc. Inanother embodiment, the surgical instrument includes a jaw-laden forcewithout mechanically coupling the force to the grasping jaw. The forcemay be carried through a wireless medium, an ethereal medium or otherintangible media. In another embodiment, the actuation mechanismconverts a manual force from the force receiver into the jaw-ladenforce. In yet another embodiment, the jaw-laden force results in releaseof at least one surgical stapler or surgical; fastener.

The following embodiments are directed to a surgical instrument that isadapted to deliver surgical fasteners and may contain at least oneshape-transforming material or at least one sensor.

In an alternative embodiment of the surgical instrument that is adaptedto deliver surgical fasteners, the surgical instrument further comprisesat least one energy module that includes at least one of a battery, acapacitor, a fuel cell, a mechanical energy storage device, or a fluidenergy storage device. At least one energy module may be located withinor in a proximity to the at least one grasping jaw. In an embodiment,least one energy module is located outside the at least one grasping jawbut is within a portion of the surgical instrument. An embodimentprovides that at least one energy module is located outside the at leastone grasping jaw.

An embodiment of the surgical instrument that is adapted to deliversurgical fasteners provides that at least one energy module transmitsenergy through a medium containing at least one of a wire, a tube, anoptical fiber or a waveguide. Alternately, at least one energy moduletransmits energy through a wireless device.

In one embodiment of the surgical instrument that is adapted to deliversurgical fasteners, at least one fastener contains oneshape-transforming material. The shape transforming material may containa shape memory alloy. The shape memory alloy may include at least one oftitanium, nickel, zinc, copper, aluminum, cadmium, platinum, iron,manganese, cobalt, gallium or tungsten. Alternatively, the shape memoryalloy includes Nitinol™ or an electro-active polymer. Alternativeembodiments call for at least one shape-transforming material to includeat least one mechanically reconfigurable material.

In an embodiment of the surgical instrument that is adapted to deliversurgical fasteners, the surgical instrument has at least one sensor thatis disposed within at least one grasping jaw. Alternatively, at leastone sensor may be disposed in a proximity to at least one grasping jaw.In an embodiment, at least one sensor includes an image-acquisitiondevice. The image-acquisition device may include at least one of acamera, a charge coupled device, an X-ray receiver, an acoustic energyreceiver, an electromagnetic energy receiver or an imaging device. In anembodiment, the image-acquisition device is wirelessly coupled to atleast one visual display. The sensor may include an illumination devicethat is operably coupled to an image-acquisition device. Alternatively,at least one sensor includes a data-transmission device. In anembodiment, the proximity detector is adapted to detect the proximity ofa biological tissue to the surgical instrument. In a further embodiment,the proximity detector includes an electromagnetic energy emitter or anelectromagnetic energy receiver. In yet another embodiment, theproximity detector includes an acoustic energy emitter and an acousticenergy receiver. In an embodiment, the proximity detector includes apoint source emitter or a source illuminator. The point source emitteror a source illuminator, in some embodiment are operably coupled to atleast one image acquisition device. Furthermore, the point sourceemitter or a source illuminator include at least one of an ultrasonicsource, an acoustic source, a visible source, an ultraviolet source, agamma ray source, an X-ray source or an infrared source. Alternativelyor additionally, point source emitter or a source illuminator areoperably configured within a grasping jaw of the surgical instrument.The proximity detector may include a communication medium forcommunication with at least one image display. In one embodiment, theproximity detector includes at least one image-transmission device. In afurther embodiment, the proximity detector includes at least onedata-transmission device. Furthermore, the proximity detector iswirelessly coupled to at least one image display.

In an embodiment of the surgical instrument that is adapted to deliversurgical fasteners, the surgical instrument comprises at least onesensor that provides a feedback signal, a datum or an image to a humanor robotic user. Additionally, at least one sensor provides a forcefeedback signal to the delivery mechanism. At least one sensor mayprovide a signal, a datum or an image regarding status of the number offasteners in the surgical instrument. Furthermore, at least one sensorprovides a signal, a datum or an image regarding functional status ormalfunctional status of the surgical instrument.

In another embodiment of the surgical instrument that is adapted todeliver surgical fasteners, the surgical instrument further comprises atleast one cutter. Additionally, in some embodiments, at least one cutteris an optical cutter. In a further embodiment, the optical cutter may bea laser-mediated cutting device. The surgical instrument may have atleast one cutter that is an electro-thermal cutter. Furthermore at leastone cutter may include one of a blade, a knife or an edge. In anembodiment, at least one cutter is operably coupled to at least onegrasping jaw.

In an embodiment of the surgical instrument that is adapted to deliversurgical fasteners, the instrument may be further configured to delivera chemical tissue sealant. In another embodiment, the chemical tissuesealant is housed inside at least one grasping jaw. In an alternativeembodiment, the chemical tissue sealant is a biocompatible chemicaltissue sealant. Furthermore the sealant may be a biodegradable chemicaltissue sealant. Additional embodiments may provide for a chemical tissuesealant that is delivered in a proximity to at least one fastener.Further, the chemical tissue sealant may be delivered between at leasttwo adjacent layers of body tissue.

In some embodiments of the surgical instrument that is adapted todeliver fasteners, the surgical instrument may deliver surgicalfasteners including staples, pins or ties. In another embodiment, thesurgical instrument may comprise at least one grasping jaw having acurvature that conforms to a body tissue or more than two grasping jaws.Further variants of embodiments of the surgical instrument may compriseof a flexually deformable and steerable shaft connected to at least onegrasping jaw. In an embodiment, the flexually deformable and steerableshaft contains at least one shape-transforming material. In someembodiments, at least one shape-transforming material contains a shapememory alloy. The shape memory alloy may include at least one oftitanium, nickel, zinc, copper, aluminum, cadmium, platinum, iron,manganese, cobalt, gallium or tungsten. In one embodiment, shape memoryalloy includes Nitinol™ or an electro-active polymer. At least oneshape-transforming material may include at least one mechanicallyreconfigurable material in an embodiment of the surgical instrument.

An aspect of a surgical instrument may comprise at least one graspingjaw and at least one delivery mechanism that may be adapted to deliversurgical fasteners. Furthermore, the delivery mechanism may be locatedin a proximity to or may be contained within the at least one graspingjaw. Moreover, the surgical fasteners may contain at least oneshape-transforming material or at least one chemical tissue sealant. Inan embodiment, at least one grasping jaw is configured to movablyoperate in an opposing manner with respect to at least one othergrasping jaw. Furthermore, at least one grasping jaw is configured tooperably mate with at least one other grasping jaw. Additionally, atleast one grasping jaw may be configured to serve as an anvil forforming an interaction surface between at least one surgical fastenerand bodily tissues, the forming being facilitated by reversible matingand unmating of the anvil with an opposite grasping jaw. In anotherembodiment, at least one grasping jaw may form an annular grasp around abody tissue. In yet another embodiment, the delivery mechanism utilizesa force generated from a force generator mechanism contained within orin proximity to at least one grasping jaw. Furthermore, the deliverymechanism results in delivery of one or more linear rows of surgicalfasteners.

The following embodiments are directed to a surgical instrument that isadapted to deliver surgical fasteners and may contain at least oneshape-transforming material or at least one chemical tissue sealant.

In one embodiment of the surgical instrument that is adapted to deliversurgical fasteners, the surgical instrument further comprises at leastone energy module that includes at least one of a battery, a capacitor,a fuel cell, a mechanical energy storage device, or a fluid energystorage device. The force is generated from the delivery mechanism mayinclude at least one of a pressurized gas canister/cartridge, a spring,a lever, an explosive charge, a piezoelectric actuator, an electricmotor, an electroactive polymer or a solenoid. In a further variant ofthe embodiment, at least one energy module is located within or in aproximity to at least one grasping jaw. Moreover, at least one energymodule may be located outside at least one grasping jaw but within aportion of the surgical instrument. Additionally, in some embodiments atleast one energy module may be located outside at least one graspingjaw. At least one energy module may transmit energy through a mediumcontaining at least one of a wire, a tube, an optical fiber or awaveguide. Alternatively, at least one energy module may transmit energythrough a wireless device.

In an embodiment of the surgical instrument that is adapted to deliversurgical fasteners, the surgical instrument may include at least oneshape-transforming material that contains a shape memory alloy. Theshape memory alloy may include at least one of titanium, nickel, zinc,copper, aluminum, cadmium, platinum, iron, manganese, cobalt, gallium ortungsten. In one embodiment, the shape memory alloy may include Nitinol™or electro-active polymer. In another embodiment, at least oneshape-transforming material includes at least one mechanicallyreconfigurable material.

In one embodiment of the surgical instrument that is adapted to deliversurgical fasteners, the surgical instrument further comprises at leastone sensor. The at least one sensor may be disposed within at least onegrasping jaw. Furthermore, at least one sensor may be disposed in aproximity to at least one grasping jaw. In one embodiment, at least onesensor includes an image-acquisition device. Furthermore, theimage-acquisition device may include at least one of a camera, a chargecoupled device, an X-ray receiver, an acoustic energy receiver, anelectromagnetic energy receiver or an imaging device. In one embodiment,the image-acquisition device may be wirelessly coupled to at least onevisual display. In an embodiment, at least one sensor includes anillumination device that is operably coupled to at least oneimage-acquisition device. In yet another embodiment, at least one sensorincludes a data-transmission device.

Furthermore, the surgical instrument adapted to deliver surgicalfasteners includes at least one sensor includes a proximity detector,which may be adapted to detect proximity of a biological tissue to thesurgical instrument. Furthermore, the proximity detector includes, inone embodiment, an electromagnetic energy emitter or an electromagneticenergy receiver. In other embodiments, the proximity detector includesan acoustic energy emitter and an acoustic energy receiver. Theproximity detector may further include a point source emitter or asource illuminator.

An embodiment, the surgical instrument that is adapted to deliversurgical fasteners provides for a point source emitter or a sourceilluminator that is operably coupled to at least one image acquisitiondevice. In another embodiment, the point source emitter or a sourceilluminator includes at least one of an ultrasonic source, an acousticsource, a visible source, an ultraviolet source, a gamma ray source, anX-ray source or an infrared source. Here the point source emitter or asource illuminator may be operably configured within a grasping jaw ofthe surgical instrument. The proximity detector may additionally includea communication medium for communication with at least one imagedisplay. In one embodiment, the proximity detector includes at least oneimage-transmission device. In another embodiment, the proximity detectorincludes at least one data-transmission device. In yet anotherembodiment, the proximity detector is wirelessly coupled to at least oneimage display. In an embodiment, at least one sensor provides a feedbacksignal, which may be a datum or an image to a human or robotic user. Inanother embodiment, at least one sensor provides a force feedback signalto a force generator mechanism. Furthermore, at least one sensor mayprovide a signal, a datum or an image regarding status of the number ofstaples in the surgical instrument.

In one embodiment, the surgical instrument that is adapted to deliversurgical fasteners, the surgical instrument further comprises at leastone cutter. Another embodiment provides at least one cutter is anoptical cutter. The optical cutter may include a laser-mediated cuttingdevice. The cutter may include at least one cutter is an electro-thermalcutter in one embodiment. Furthermore, at least one cutter may includeone of a blade, a knife or an edge. In another embodiment, at least onecutter is operably coupled to at least one grasping jaw.

In an embodiment, the surgical instrument that is adapted to deliversurgical fasteners includes a chemical tissue sealant is housed insideat least one grasping law. In another embodiment, the chemical tissuesealant is a biocompatible chemical tissue sealant or a biodegradablechemical tissue sealant. In yet another embodiment, the chemical tissuesealant is delivered in a proximity to at least one fastener. One otherembodiment provides for a chemical tissue sealant that is deliveredbetween at least two adjacent layers of body tissue.

In some embodiments, the surgical instrument that is adapted to deliversurgical fasteners includes the surgical instrument delivers surgicalfasteners that include staples, pins or ties. The surgical instrumentmay have at least one grasping jaw that has a curvature that conforms toa body tissue. Furthermore, more than two grasping jaws may be includedin the surgical instrument.

Moreover, the surgical instrument that is adapted to deliver surgicalfasteners may comprise a flexually deformable and steerable shaftconnected to at least one grasping jaw, and may contain at least oneshape-transforming material. In some embodiments, the at least oneshape-transforming material contains a shape memory alloy. The shapememory alloy may include at least one of titanium, nickel, zinc, copper,aluminum, cadmium, platinum, iron, manganese, cobalt, gallium ortungsten. In some embodiments, the shape memory alloy includes Nitinol™or electro-active polymer. In an embodiment, the shape-transformingmaterial includes at least one mechanically reconfigurable material.

In one aspect, an embodiment of the surgical instrument comprises atleast one grasping jaw or at least one delivery mechanism adapted todeliver surgical fasteners. The delivery mechanism being located in aproximity to or is contained within at least one grasping jaw. In someembodiments, the surgical fasteners contain at least oneshape-transforming material or at least one cutter. At least onegrasping jaw is configured to movably operate in an opposing manner withrespect to at least one other grasping jaw. In another embodiment, atleast one grasping jaw is configured to operably mate with at least oneother grasping jaw. Furthermore, at least one grasping jaw is configuredto serve as an anvil for forming an interaction surface between at leastone surgical fastener and bodily tissues, the forming being facilitatedby reversible mating and unmating of the anvil with an opposite graspingjaw. In an embodiment, at least one grasping jaw forms an annular grasparound a body tissue.

The following embodiments are directed to a surgical instrument that isadapted to deliver surgical fasteners and may contain at least oneshape-transforming material or at least one cutter.

One embodiment of the surgical instrument adapted to deliver surgicalfasteners provides that a delivery mechanism utilizes a force generatedfrom the delivery mechanism contained within or in a proximity to atleast one grasping jaw. Another provides that the delivery mechanismresults in delivery of one or more linear rows of surgical fasteners.Furthermore, the force is generated from the delivery mechanism thatincludes at least one of a pressurized gas canister/cartridge, a spring,a lever, an explosive charge, a piezoelectric actuator, an electricmotor, an electroactive polymer or a solenoid.

The surgical instrument that is adapted to deliver surgical fastenersfurther comprises at least one energy module that includes at least oneof a battery, a capacitor, a fuel cell, a mechanical energy storagedevice, or a fluid energy storage device. In an embodiment, at least oneenergy module is located within or in a proximity to at least onegrasping jaw.

Yet another embodiment the surgical instrument that is adapted todeliver surgical fasteners includes at least one energy module that islocated outside at least one grasping jaw but within a portion of thesurgical instrument. Furthermore, at least one energy module may belocated outside at least one grasping jaw. In addition, at least oneenergy module may transmit energy through a medium containing at leastone of a wire, a tube, an optical fiber or a waveguide. Alternatively,at least one energy module transmits energy through a wireless device.

In an embodiment of the surgical instrument that is adapted to deliversurgical fasteners, at least one surgical fastener contains oneshape-transforming material, which may include a shape memory alloy. Theshape memory alloy may further include at least one of titanium, nickel,zinc, copper, aluminum, cadmium, platinum, iron, manganese, cobalt,gallium or tungsten. Alternatively, shape memory alloy includes Nitinol™or electro-active polymer. An embodiment may have at least oneshape-transforming material that includes at least one mechanicallyreconfigurable material.

In an embodiment, the surgical instrument that is adapted to deliversurgical fasteners further comprises at least one sensor. In anotherembodiment, at least one sensor is disposed within at least one graspingjaw. Yet another embodiment may include at least one sensor that isdisposed in a proximity to at least one grasping jaw. Furthermore, atleast one sensor may include an image-acquisition device. Theimage-acquisition device may include at least one of a camera, a chargecoupled device, an X-ray receiver, an acoustic energy receiver, anelectromagnetic energy receiver or an imaging device. Furthermore, theimage-acquisition device may be wirelessly coupled to at least onevisual display. The sensor may include an illumination device that isoperably coupled to at least one image-acquisition device. In anembodiment, at least one sensor includes a data-transmission device.Furthermore, at least one sensor includes a proximity detector. Theproximity detector may be adapted to detect proximity of a biologicaltissue to the surgical instrument. Furthermore, proximity detector mayinclude an electromagnetic energy emitter or an electromagnetic energyreceiver. In another embodiment, the proximity detector includes anacoustic energy emitter and an acoustic energy receiver. The proximitydetector may further include a point source emitter or a sourceilluminator. Additional embodiments may include the point source emitteror a source illuminator being operably coupled to at least one imageacquisition device. In another embodiment, the point source emitter or asource illuminator includes at least one of an ultrasonic source, anacoustic source, a visible source, an ultraviolet source, a gamma raysource, an X-ray source or an infrared source. In yet anotherembodiment, the point source emitter or a source illuminator is operablyconfigured within a grasping jaw. Still another embodiment includes aproximity detector that may communicate through a medium with at leastone image display. An embodiment provides that the proximity detectorincludes a communication medium for communication with at least oneimage display. Furthermore, the proximity detector includes at least onedata-transmission device. In another embodiment, the proximity detectoris wirelessly coupled to at least one image display. Yet anotherembodiment, at least one sensor provides a feedback signal, a datum oran image to a human or robotic user. Still another embodiment providesthat at least one sensor communicates a force feedback signal to a forcegenerator mechanism. At least one sensor provides a signal, a datum oran image regarding status of the number of staples in the surgicalinstrument.

An embodiment, the surgical instrument that is adapted to deliversurgical fasteners has at least one cutter that may be an opticalcutter. The optical cutter may be a laser-mediated cutting device. Atleast one cutter may be an electro-thermal cutter. In anotherembodiment, least one cutter includes one of a blade, a knife or anedge. In yet another embodiment, at least one cutter is operably coupledto at least one grasping jaw.

In an embodiment, the surgical instrument that is adapted to deliversurgical fasteners further comprises a chemical tissue sealant. Thechemical tissue sealant may be housed inside at least one grasping jaw.Another embodiment provides that the chemical tissue sealant is abiocompatible chemical tissue sealant. Further embodiments specify thatthe chemical tissue sealant is a biodegradable chemical tissue sealant.Still another embodiment provides that the chemical tissue sealant bedelivered in a proximity to at least one fastener and is deliveredbetween at least two adjacent layers of body tissue.

In one embodiment, surgical fasteners include staples, pins or ties. Thesurgical instrument further comprises in an embodiment at least onegrasping jaw having a curvature that conforms to a body tissue.Furthermore the surgical instrument comprises more than two graspingjaws. The surgical instrument may further comprise a flexuallydeformable and steerable shaft connected to at least one grasping jaw.Embodiments of the flexually deformable and steerable shaft may containat least one shape-transforming material. Furthermore, at least oneshape-transforming material contains a shape memory alloy, which maycontain at least one of titanium, nickel, zinc, copper, aluminum,cadmium, platinum, iron, manganese, cobalt, gallium or tungsten. Theshape memory alloy may include Nitinol™ or electro-active polymer or atleast one mechanically reconfigurable material.

A further aspect of a surgical instrument involves a method of splicingbody organs/tissues. In an embodiment, the method comprises the steps ofgrasping a body tissue with at least one grasping jaw; adjusting aconfiguration of the grasping in response to a signal or a datum or animage; and releasing a surgical staple/fastener in response to thesignal, datum or image. In another embodiment, the method includesgrasping a body tissue includes performing end-to-end anastomosis,side-to-side anastomosis, individual ligation, endoscopic orlaparoscopic gastro-intestinal operations which include at least one ofa bronchus, a pulmonary artery, a pulmonary vein, a large or smallintestine, a stomach, a blood vessel or skin. The grasping a body tissuemay include aligning the body organs between the at least one graspingjaw in a manner compatible with surgical or anastomosis operations. Inan embodiment, the grasping operation may include displaying an image ofthe tissue being grasped. Furthermore, adjusting a configuration of thegrasping includes annularly adjusting a grasp around the organs/tissuesbased on the signal or datum or image. In another embodiment, thereleasing of a surgical staple/fastener includes driving a plurality ofstaple/fasteners into at least one layer of body tissue. In stillanother embodiment, releasing a surgical staple/fastener includessecuring at least one layer of a body tissue with the surgicalstaple/fastener. In yet another embodiment, releasing a surgicalstaple/fastener includes deformation of one or more staple/fastenersthat undergo a conformational change to close a puncture site.Furthermore, releasing a surgical staple/fastener includes closing atleast one or more wound sites. The method may additionally includereleasing a surgical staple/fastener and a suitable amount of a chemicaltissue sealant that permits wound healing.

An aspect of a surgical instrument includes a method of splicing bodyorgans/tissues comprising: means for grasping a body tissue; means foradjusting a configuration of the grasping in response to a signal or adatum or an image; and means for releasing a surgical staple/fastener inresponse to the signal, datum or image.

In addition to the foregoing, other system aspects are described in theclaims, drawings, and text forming a part of the present disclosure.Furthermore, various other method or system or program product aspectsare set forth and described in the teachings such as text (e.g., claimsor detailed description) or drawings of the present disclosure.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects, embodiments,and features described above, further aspects, embodiments, and featureswill become apparent by reference to the drawings and the followingdetailed description.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a system-level illustration of an exemplary surgicalinstrument in which embodiments such as grasping jaws and an exemplaryforce generator mechanism may be implemented;

FIG. 2 is a schematic of a surgical instrument that includes anexemplary illustrative embodiment of movable grasping jaws that includesan exemplary illustration of a force generator mechanism;

FIG. 3 is a schematic of a surgical instrument that includes anexemplary illustrative embodiment of closed mating position of movablegrasping jaws that includes an exemplary illustration of a forcegenerator mechanism;

FIG. 4 is a schematic of a surgical instrument that includes anillustrative example of mating grasping jaws configured to grasp tubularorgans/tissues;

FIG. 5 is a schematic of a surgical instrument including an exemplaryillustration of two grasping jaws adapted to provide an annular grasparound an exemplary illustration of a bodily organ;

FIG. 6 is a schematic of a surgical instrument including an exemplaryillustration of a force generator mechanism that is configured todeliver an exemplary illustration of a linear row of staples into anexemplary illustration of a bodily tissue;

FIG. 7 is a schematic of a surgical instrument that includes anexemplary illustration of a split force generator mechanism located inboth illustrative grasping jaws;

FIG. 8 is a schematic of a surgical instrument that includes anexemplary illustration of an example of a flexually deformable andsteerable shaft;

FIG. 9 is a schematic of a surgical instrument including exemplaryillustration of shape-conforming grasping jaws with exemplary sensors;

FIG. 10 is a schematic of a surgical instrument including an exemplaryillustration of a grasping jaw housing a delivery mechanism fordelivering an exemplary fasteners and an illustrative example of achemical tissue sealant;

FIG. 11 is a schematic of a surgical instrument including an exemplaryillustration of a portion of a chemical tissue sealant deposited inproximity to an exemplary row of surgical fasteners;

FIG. 12 is a schematic of a surgical instrument including an exemplaryillustration of a portion of a chemical tissue sealant deposited inproximity to an exemplary illustration of layers of bodily tissues;

FIG. 13 is a schematic of a surgical instrument including an exemplaryillustration of a sensor includes an exemplary illustration of an imageacquisition device;

FIG. 14 is a schematic of a surgical instrument including a pair ofgrasping jaws includes an exemplary illustration of sensors withexemplary illustrations of image acquisition devices in communicationwith at least one image display;

FIG. 15 is a schematic of a surgical instrument including exemplaryillustrations of sensors including exemplary an illustration of an imageacquisition device and an exemplary illustration of a data-transmissiondevice;

FIG. 16 is a schematic of a surgical instrument including an exemplaryillustration of a proximity detector;

FIG. 17 is a schematic of a surgical instrument including an exemplaryillustration of an image acquisition device, an exemplary illustrationof a communication medium and an exemplary illustration of a visualdisplay;

FIG. 18 is a schematic of a surgical instrument including an exemplaryillustration of a fastener or staple holder or housing containing anexemplary illustration of an assortment of fasteners/staples;

FIG. 19 is a schematic of a surgical instrument including an exemplaryillustration of detachable grasping jaws;

FIG. 20 is a schematic of a surgical instrument including an exemplaryillustration of a cutting device;

FIG. 21 is a schematic of a surgical instrument including an exemplaryillustration of a force feedback signal;

FIG. 22 illustrates embodiments of an exemplary operational flow fordisplaying an image;

FIG. 23 illustrates embodiments of an exemplary operational flow forgrasping a body organ or tissue;

FIG. 24 illustrates embodiments of an exemplary operational flow foradjusting a configuration of grasping a body organ or tissue;

FIG. 25 illustrates embodiments of an exemplary operational flow forreleasing a surgical fastener;

FIG. 26 illustrates embodiments for an exemplary surgical instrument.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description, drawings, and claims are not meant to be limiting.Other embodiments may be utilized, and other changes may be made,without departing from the spirit or scope of the subject matterpresented here.

The following disclosure is drawn to a surgical instrument. FIG. 1 showsa system-level schematic illustration of an embodiment of the surgicalinstrument 100 comprising at least one grasping jaw 110, the at leastone grasping jaw being adapted to deliver surgical staples 120 by aforce generated from a force generator mechanism 130 that is containedwithin the at least one grasping jaw 110 or is in a proximity to the atleast one grasping jaw. The grasping jaws 110, 112 may be movably 140attached to a hinge 630. At a system level, the surgical instrumentfurther comprises control circuitry that may control one or more partsof the surgical instrument. Additionally, the surgical instrument mayoptionally include a hinge 630 that connects the jaws. There is includeda shaft 270 connecting the jaws or hinge to a handgrip 590. The handgripincludes a trigger 610. The handgrip includes a signal generator 540that is capable of communicating a signal 550. In some embodiments ofthe surgical instrument the trigger/handgrip is adapted to receive afeedback signal 600 that may communicate to a user information regardingthe functional status of the surgical instrument.

As used herein, the terms “grasping jaws” or “jaws” include, but are notlimited to, any of the various parts or whole of a surgical stapler orparts thereof or similar surgical stapling or anastomosis devices.Illustrative examples of such staplers, stapling devices or anastomosisdevices may be those suitable for use in any medical or surgical careincluding performing end-to-end anastomosis, side-to-side anastomosis,individual ligation, endoscopic or laparoscopic gastro-intestinaloperations. Such operations may involve for example, at least one of abronchus, a pulmonary artery, a pulmonary vein, a large or smallintestine, a stomach, a blood vessel or skin.

Turning now to FIG. 2, which is an exemplary illustration of a surgicalinstrument 100 wherein at least one grasping jaw 110 is configured tomovably 140 operate in an opposing manner with respect to at least oneother grasping jaw 112.

FIG. 3 illustrates an exemplary surgical instrument 100 showing anembodiment of at least one grasping jaw 110 that is configured tooperably mate 150 with at least one other grasping jaw 112. The term“mate” includes, but is not limited to, juxtapositioning, “comingtogether” or aligning any or all parts of each grasping jaw. Matingincludes, but is not limited to, complete or partial coupling of thegrasping of the jaws.

As illustrated in FIG. 4, at least one grasping jaw 112 is configured toserve as an anvil 160 for forming an interaction surface 162 between atleast one surgical staple 170 and bodily tissues 180, the forming beingfacilitated by reversible mating and unmating 190 of the anvil with anopposite grasping jaw 112. Those skilled in the art will recognize thatmating and unmating of the grasping jaws may be limited to the movementof at least one grasping jaw while the other grasping jaw may bestationary. Furthermore, the illustration in FIG. 4 does not necessarilylimit the surgical instrument to only two jaws. One skilled in the artmay envisage similar surgical instruments with more than two graspingjaws that are aligned to achieve the same or similar results illustratedin FIG. 4.

FIG. 5 shows an exemplary embodiment of a surgical instrument 100illustrating at least one grasping jaw 110 that forms an annular grasp200 around a body tissue 210. In another embodiment, the other graspingjaw 112 may form a complementary annular grasp 212. Those skilled in theart will realize that the grasping jaws may be configured to alter theshape and size of the grasping surface based on the size and shape ofthe bodily organs or tissues. In other words, grasping jaws may beconstructed in different sizes and shapes to fit the various bodilyorgans and tissues of patients. Furthermore, one or more grasping jawsmay be configured to enter the lumen of tubular organs duringanastomosis procedures.

In an embodiment, the terms “bodily”, “body” or “patient” refer to ahuman or any animal including domestic, marine, research, zoo, farmanimals, fowl and sports animals, or pet animals, such as dogs, cats,cattle, horses, sheep, pigs, goats, rabbits, chickens, birds, fish,amphibian and reptile.

In an embodiment, the terms “tissue(s)” or “organs” includes any part ofa human or animal body. Examples may include but is not limited to,organs associated with the alimentary canal/digestive tract, pulmonarytract, blood vessels, lumen-containing organs, bones, etc.

Looking at FIG. 6, in an embodiment of a surgical instrument 100, aforce 220 generated from a force generator mechanism 130 is communicatedto a medium: 230 resulting in the release of one or more linear rows 240of surgical staples. The force may be generated by a variety of means.In an embodiment, such means may include but are not limited to, anenergy module 250. The energy module may include at least one of abattery, a capacitor, a fuel cell, a mechanical energy storage device,or a fluid energy storage device. In another embodiment, the force maybe generated through the use of a number of devices, which may includebut are not limited to at least one of a pressurized gascanister/cartridge, a spring, a lever, an explosive charge, apiezoelectric actuator, an electric motor, an electroactive polymer or asolenoid.

In an embodiment, as illustratively exemplified in FIG. 7, at least oneenergy module 250 may be located within the opposing grasping jaw 112(or in a proximity to it). Furthermore, the energy module transmitsenergy 254 through a wireless device 252 to the remotely located forcegenerator mechanism 130. In alternative embodiments, the energy modulemay transmit energy via a medium that includes but is not limited to atleast one of a wire, a tube, an optical fiber or a waveguide.

FIG. 8 illustrates a further variation of an exemplary surgicalinstrument 100. Here, an embodiment further illustrates two graspingjaws 110, 112 that are connected to a flexually deformable and steerableshaft 270 that is connected to the grasping jaw. In an embodiment, theshaft may be connected to the jaws via a hinge 630. In anotherembodiment, the flexually deformable and steerable shaft contains atleast one shape-transforming material 280, which may permit complete orpartial deformation 260 of the shaft. Deformation of the shaft mayincrease the capability of the surgical instrument because the humanuser may move 262 the handgrip 590 of the surgical instrument innumerous directions, thus enabling the use of the surgical instrument inhard-to-reach areas of the patient's body and around anatomical corners.The shape-transforming material may contain a shape memory alloy orother materials responsive to an input to change shape or physicaldimension or characteristic. Examples of shape memory alloy include, butare not limited to, Nitinol™. In addition, embodiments may include atleast one of titanium, nickel, zinc, copper, aluminum, cadmium,platinum, iron, manganese, cobalt, gallium or tungsten. Some materialsmay contain electro-active polymers or mechanically reconfigurablematerial.

Turning now to FIG. 9, which illustrates an embodiment of a pair ofgrasping jaws 110, 112. In this example, the grasping jaws may be shapeddifferently from those exemplified in the above figures and may befurther adapted to conform to a shape 320 of a body organ or tissue 210.Conformity may be achieved, inter alia, through the use of shapetransforming material 300 provided within the whole or part of thegrasping jaws. The shape-transforming material may be distributed ineither or both grasping jaws. In an embodiment, at least one sensor 310may be disposed in one or more of the grasping jaws.

In an embodiment of a surgical instrument 100, as illustrated in FIG.10, at least one grasping jaw 110 and at least one delivery mechanism132 are adapted to deliver exemplary surgical fasteners 340, 350.Moreover in another embodiment, the delivery mechanism may be containedwithin at least one grasping jaw 110. Alternatively, the deliverymechanism may be in proximity to a grasping jaw but not within it. Here,the location may include, but is not limited to, another grasping jaw oranother portion of the surgical instrument. In yet another embodiment,the surgical fasteners may contain at least one shape-transformingmaterial 350. In still another embodiment, at least one grasping jaw 112may provide at least one chemical tissue sealant 360. The tissue sealantmay be housed in a reservoir 370.

FIG. 11 illustrates an embodiment of a surgical instrument 100, in whicha portion 380 of the chemical tissue sealant 360 is delivered in aproximity to illustrative surgical fasteners 340. The sealant may beapplied prior to or after the deployment of the surgical fasteners 340,350. Here, a portion of the chemical tissue sealant, includes, but isnot limited to a drop(s) or droplets or spray or liquid or solid orsemi-solid. Further embodiments include the delivery of the chemicaltissue sealant in proximity to released fasteners 340, 350.

FIG. 12 illustrates that, in an embodiment, the chemical tissue sealantportion 380 may be delivered between at least two adjacent layers 390 ofbody tissue. Those skilled in the art are aware that here “adjacentlayers” includes, and is not limited to, tissue or organs broughttogether in close proximity to each other during anastomosis operations.The organs or tissues may lie on top of each other or within each otheror on a side by side position with respect to each other or in any otherposition with respect to each other. As used here, the term “layers”includes monolayers, bilayers, multilayers, a single layer, and includesone or more layers of body tissue.

FIG. 13 shows an embodiment of a surgical instrument 100 having twograsping jaws 110, 112 configured to grasp bodily tissues/organs 210.This exemplary illustration further shows at least one grasping jaw 110that includes at least one sensor 310. In a further embodiment, theother grasping jaw 112 is illustratively shown to carry a sensor 310 aswell. In another embodiment, at least one sensor includes animage-acquisition device 400. In yet another embodiment,image-acquisition device includes at least one imaging device 410, whichmay include but is not limited to one of a lens, a camera, a chargecoupled device, an X-ray receiver, an acoustic energy receiver, anelectromagnetic energy receiver.

In still another embodiment, as illustrated in FIG. 14, a surgicalinstrument 100 may include one or more sensors 310 and image acquisitiondevices 400. The image acquisition devices may transmit images via awireless communication medium 420 that is operably coupled with at leastone image display 430. The communication medium may include, inter alia,hardwire and at least one image-transmission devices. In an embodimentthe image transmission devices may be built into the hardware in theimage acquisition devices. Those skilled in the art will recognize thatimage transmission devices may include those devices which may be usedfor transmitting encoded data obtained by encoding the data of an image.Examples of image transmission devices are given, for instance, in U.S.Pat. No. 5,305,116 and U.S. Pat. No. 6,157,675, both of which areincorporated herein by reference.

FIG. 15 illustrates at least one sensor 310 that includes adata-transmission device 440. In another embodiment, the surgicalinstrument 100 may include two grasping jaws 110, 112 that may have twoseparate sensors 310 each includes either an image acquisition device400 or a data transmission device 440. Those skilled in the art willrealize that some surgical instruments may include more than twograsping jaws containing more than two image acquisition devices or dataacquisition devices.

Turning to FIG. 16, there is illustrated an embodiment of a surgicalinstrument 100 that includes at least one grasping jaw 112 that includesa sensor 310 which in turn may include a proximity detector 450. In anembodiment, the proximity detector is adapted to detect proximity of abiological tissue 460 to the surgical instrument 100. In anotherembodiment, the proximity detector includes an electromagnetic energyemitter or an electromagnetic energy receiver. In yet anotherembodiment, the proximity detector includes a point source emitter 480or a source illuminator. In still another embodiment, the point sourceemitter or a source illuminator emits electromagnetic or acoustic energy470. The energy emitter includes at least one of an ultrasonic source,an acoustic source, a visible source, an ultraviolet source, a gamma raysource, an X-ray source or an infrared source.

FIG. 17 schematically illustrates an exemplary proximity detector 450that includes a communication medium 490 for communication with at leastone image display 430. One skilled in the art will realize thatcommunication includes, but is not limited to, image transmission, datatransmission, digital data transmission, analogue data transmission oran audio transmission. One skilled in the art will also recognize thatexamples of communication media include, but are not limited to thefollowing devices: a wire, a tube, an optical fiber, a waveguide orwireless devices.

There is illustrated in an embodiment shown in FIG. 18 a surgicalinstrument 100 comprising multiple types of surgical fasteners made froman assortment of materials. In an embodiment, one surgical instrument100 may house 500 exemplary surgical staples made from, for instance,shape transforming material 510 or mechanically reconfigurable material512. One skilled in the art will recognize that multiple types ofsurgical fasteners include, but are not limited to surgical fastenersmade from different types of materials/compositions, chemical orelectrical properties, different shapes and sizes of fasteners,including biocompatible, biodegradable materials. One skilled in the artwill further recognize that the above term “house” includes but is notlimited to fastener/stapler cartridge holders and the like that areavailable in the commercial market, and those that are custom-designedand made to fit into surgical stapler-type medical instruments.

In FIG. 19, there is shown an embodiment of a surgical instrument 100wherein the exemplary grasping jaws 110, 112 are configured to becomedetachable 520. Those skilled in the art will recognize thatdetachability of grasping jaws includes, but is not limited to,replacement of used grasping jaws with new ones and disposable graspingjaws. In an embodiment, one or more grasping jaws may be replacedsequentially or simultaneously. Furthermore, detachability of graspingjaws includes, inter alia, replacement grasping jaws of different sizesand shapes or grasping jaws made from different materials/compositionsof materials.

Turning to FIG. 20, which schematically illustrates an embodiment of asurgical instrument 100 containing an exemplary illustration of acutting device 530. The surgical instrument may further comprise atleast one grasping jaw 110, 112 and a deformable and steerable shaft 270made from shape transformation material 280. The cutting device mayinclude, but is not limited to, at least one cutter. As recognized bythose skilled in the art, cutters may include optical cutters,laser-mediated cutting devices, electro-thermal cutters, a blade, aknife or an edge.

FIG. 21 illustrates an embodiment of a surgical instrument 100 thatincludes a handgrip 590. The handgrip includes a trigger 610. Thehandgrip further includes a signal generator 540 that is capable ofcommunicating signals 550. In an embodiment, the trigger/handgrip isadapted to receive one or more feedback signals 600 that may communicateto a human or robotic user information regarding the functional statusof the surgical instrument. The signals may be, for example, generatedby parts within the fastener/staple delivery mechanism 132. Thoseskilled in the art will appreciate that the term trigger includes, butis not limited to devices such as, pushbutton or lever or latch etc.Furthermore those skilled in the art will recognize that here the term“functional status” includes delivery status of surgicalfasteners/staples (including whether a fastener or staple has beenreleased by the instrument and whether the fastener/staple has beendelivered into a bodily tissue in a correct or incorrect manner), numberof staples/fasteners remaining in the surgical instrument, any defectivesurgical staples/fasteners in the surgical instrument, jammed surgicalstaples/fasteners or general malfunction of the surgical instrument. Oneskilled in the art will recognize that the feedback signals may include,inter alia, signals emanating as consequence of an operation of afastener delivery mechanism 132.

Those skilled in the art will recognize that any type of feedback signalmay be applied. Such signals may be optical, acoustic, provide forcefeedback, vibrational etc. The force feedback signal as shown in FIG. 21is provided to the trigger and handle but it can be provided to anyother area of the surgical instrument 100. The instrument may includesuch devices as an LED light, which may be disposed on the handle ineasy view that responds to a feedback signal.

In an embodiment illustrated in FIG. 22, an exemplary operation flow 700for a method of splicing body organs/tissues comprises: grasping a bodytissue with at least one grasping jaw 710; adjusting a configuration ofthe grasping in response to a signal or a datum or an image 720 providedby the instrument; and releasing a surgical staple/fastener in responseto a signal, a datum or an image 730 provided by the instrument.

As illustrated in FIG. 23, an exemplary operational flow for grasping abody tissue with at least one grasping jaw 710 may further include:performing endoscopic or laparoscopic gastro-intestinal operations 712;end-to-end or side to side anastomosis operations, individual ligation,endoscopic or laparoscopic operations or gastro-intestinal operations714; aligning body organs between at least one grasping jaw in a mannercompatible with one or more above listed operations 716; and displayingimages of tissue 718.

In an embodiment, there is illustrated in FIG. 24 an exemplaryoperational flow 720 for implementing a step of adjusting aconfiguration of grasping in response to a signal or a datum or animage. This step optionally includes annularly adjusting a grasp ofgrasping jaws around tubular organs/tissues based on signal or datum orimage 722.

FIG. 25 shows another embodiment as provided by the instrument forreleasing a surgical staple/fastener in response to signal, datum orimage 730. This operation optionally includes the following exemplarysteps: driving a plurality of staples/fasteners into at least one layerof body tissue 731; securing at least one layer of a body tissue withsurgical staples/fasteners 732; deformation of one or more fastenersthat undergo a conformational change to close a puncture site 733;closing at least one or more wound sites 734; and releasing a suitableamount of a chemical tissue sealant that permits wound healing 735.

As illustrated in FIG. 26, an embodiment of an exemplary surgicalinstrument includes: means for grasping a body tissue 810; means foradjusting a configuration of grasping in response to a signal or a datumor an image 820; means for releasing a surgical staple/fastener inresponse to signal, datum or image 830.

The foregoing detailed description has set forth various embodiments ofthe devices or processes via the use of flowcharts, diagrams, figures orexamples. Insofar as such flowcharts, diagrams, figures or examplescontain one or more functions or operations, it will be understood bythose within the art that each function or operation within suchflowchart, diagram, figure or example can be implemented, individuallyor collectively, by a wide range of any combination thereof.

One skilled in the art will recognize that the herein describedcomponents (e.g., steps), devices, and objects and the discussionaccompanying them are used as examples for the sake of conceptualclarity and that various configuration modifications are within theskill of those in the art. Consequently, as used herein, the specificexemplars set forth and the accompanying discussion are intended to berepresentative of their more general classes. In general, use of anyspecific exemplar herein is also intended to be representative of itsclass, and the non-inclusion of such specific components (e.g., steps),devices, and objects herein should not be taken as indicating thatlimitation is desired.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted figures are merelyexemplary, and that in fact many other figures can be implemented whichachieve the same functionality. In a conceptual sense, any arrangementof components to achieve the same functionality is effectively“associated” or “coupled” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected”, or“operably coupled”, to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable”, to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to, physically mateable or physically interacting componentsor wirelessly interactable or wirelessly interacting components orlogically interacting or logically interactable components.

In a general sense, those skilled in the art will recognize that thevarious aspects described herein which can be implemented, individuallyor collectively, by a wide range of hardware, software, firmware, or anycombination thereof can be viewed as being composed of various types of“electrical circuitry.” Consequently, as used herein “electricalcircuitry” includes, but is not limited to, electrical circuitry havingat least one discrete electrical circuit, electrical circuitry having atleast one integrated circuit, electrical circuitry having at least oneapplication specific integrated circuit, electrical circuitry forming ageneral purpose computing device configured by a computer program (e.g.,a general purpose computer configured by a computer program which atleast partially carries out processes or devices described herein, or amicroprocessor configured by a computer program which at least partiallycarries out processes or devices described herein), electrical circuitryforming a memory device (e.g., forms of random access memory), orelectrical circuitry forming a communications device (e.g., a modem,communications switch, or optical-electrical equipment). Those havingskill in the art will recognize that the subject matter described hereinmay be implemented in an analog or digital fashion or some combinationthereof.

Those skilled in the art will recognize that it is common within the artto describe devices or processes in the fashion set forth herein, andthereafter use engineering practices to integrate such described devicesor processes into image processing systems. That is, at least a portionof the devices or processes described herein can be integrated into animage processing system via a reasonable amount of experimentation.Those having skill in the art will recognize that a typical imageprocessing system generally includes one or more of a system unithousing, a video display device, a memory such as volatile andnon-volatile memory, processors such as microprocessors and digitalsignal processors, computational entities such as operating systems,drivers, and applications programs, one or more interaction devices,such as a touch pad or screen, control systems including feedback loopsand control motors (e.g., feedback for sensing lens position orvelocity; control motors for moving/distorting lenses to give desiredfocuses). A typical image processing system may be implemented utilizingany suitable commercially available components, such as those typicallyfound in digital still systems or digital motion systems.

One skilled in the art will recognize that the herein describedcomponents (e.g., steps), devices, and objects and the discussionaccompanying them are used as examples for the sake of conceptualclarity and that various configuration modifications are within theskill of those in the art. Consequently, as used herein, the specificexemplars set forth and the accompanying discussion are intended to berepresentative of their more general classes. In general, use of anyspecific exemplar herein is also intended to be representative of itsclass, and the non-inclusion of such specific components (e.g., steps),devices, and objects herein should not be taken as indicating that alimitation is desired.

With respect to the use of substantially any plural or singular termsherein, those having skill in the art can translate from the plural tothe singular or from the singular to the plural as is appropriate to thecontext or application. The various singular/plural permutations are notexpressly set forth herein for sake of clarity.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely exemplary, and that in fact many other architectures can beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “operably coupled” or “coupled” or “in communication with”or “communicates with” or “operatively communicate” such other objectsthat the desired functionality is achieved. Hence, any two componentsherein combined to achieve a particular functionality can be seen asassociated with each other such that the desired functionality isachieved, irrespective of architectures or intermedial components.Likewise, any two components so associated can also be viewed as being“connected”, or “attached”, to each other to achieve the desiredfunctionality, and any two components capable of being so associated canalso be viewed as being “operably couplable”, to each other to achievethe desired functionality.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to those skilled inthe art that, based upon the embodiments herein, changes andmodifications may be made without departing from the subject matterdescribed herein and its broader aspects and, therefore, the appendedclaims are to encompass within their scope all such changes andmodifications as are within the true spirit and scope of the subjectmatter described herein. Furthermore, it is to be understood that theinvention is defined by the appended claims. It will be understood bythose within the art that, in general, terms used herein, and especiallyin the appended claims (e.g., bodies of the appended claims) aregenerally intended as “open” terms (e.g., the term “including” should beinterpreted as “including but not limited to,” the term “having” shouldbe interpreted as “having at least,” the term “includes” should beinterpreted as “includes but is not limited to,” etc.). It will befurther understood by those within the art that if a specific number ofan introduced claim recitation is intended, such an intent will beexplicitly recited in the claim, and in the absence of such recitationno such intent is present. For example, as an aid to understanding, thefollowing appended claims may contain usage of the introductory phrases“at least one” and “one or more” to introduce claim recitations.However, the use of such phrases should not be construed to imply thatthe introduction of a claim recitation by the indefinite articles “a” or“an” limits any particular claim containing such introduced claimrecitation to inventions containing only one such recitation, even whenthe same claim includes the introductory phrases “one or more” or “atleast one” and indefinite articles such as “a” or “an” (e.g., “a” or“an” should typically be interpreted to mean “at least one” or “one ormore”); the same holds true for the use of definite articles used tointroduce claim recitations. In addition, even if a specific number ofan introduced claim recitation is explicitly recited, those skilled inthe art will recognize that such recitation should typically beinterpreted to mean at least the recited number (e.g., the barerecitation of “two recitations,” without other modifiers, typicallymeans at least two recitations, or two or more recitations).Furthermore, in those instances where a convention analogous to “atleast one of A, B, and C, etc.” is used, in general such a constructionis intended in the sense one having skill in the art would understandthe convention (e.g., “a system having at least one of A, B, and C”would include but not be limited to systems that have A alone, B alone,C alone, A and B together, A and C together, B and C together, or A, B,and C together, etc.). In those instances where a convention analogousto “at least one of A, B, or C, etc.” is used, in general such aconstruction is intended in the sense one having skill in the art wouldunderstand the convention (e.g., “a system having at least one of A, B,or C” would include but not be limited to systems that have A alone, Balone, C alone, A and B together, A and C together, B and C together, orA, B, and C together, etc.). It will be further understood by thosewithin the art that virtually any disjunctive word or phrase presentingtwo or more alternative terms, whether in the description, claims, ordrawings, should be understood to contemplate the possibilities ofincluding one of the terms, either of the terms, or both terms. Forexample, the phrase “A or B” will be understood to include thepossibilities of “A” or “B” or “A and B.

1. A surgical instrument comprising: a flexually deformable andsteerable shaft including at least one shape memory alloy, operablyconnected to at least one grasping jaw configured for grasping a bodytissue, and adapted to deliver surgical staples, and at least oneimage-acquisition device contained within the grasping jaw.
 2. Thesurgical instrument of claim 1, wherein the image-acquisition deviceincludes at least one of a camera, charge coupled device, X-rayreceiver, acoustic energy receiver, photodetector, electromagneticenergy receiver, or imaging device.
 3. The surgical instrument of claim1, wherein the image-acquisition device is operably coupled to anillumination device.
 4. The surgical instrument of claim 1, wherein theimage-acquisition device is wirelessly coupled to at least one visualdisplay.
 5. The surgical instrument of claim 1, wherein the at least oneshape memory alloy includes at least one of titanium, nickel, zinc,copper, aluminum, cadmium, platinum, iron, manganese, cobalt, gallium ortungsten.
 6. The surgical instrument of claim 1, wherein the at leastone shape memory alloy is preconfigured to a particular application andto a body part geometry.
 7. The surgical instrument of claim 1, whereinthe at least one shape memory alloy assumes a different shape comparedto an originally preconfigured shape to conform to an optimalorientation upon insertion of the surgical instrument into a body. 8.The surgical instrument of claim 1, wherein the shape memory alloyincludes Nitinol™.
 9. The surgical instrument of claim 1, wherein the atleast one shape memory alloy includes electro-active polymer.
 10. Thesurgical instrument of claim 1, wherein the flexually deformable andsteerable shaft being controllably deformable to permit a high degree ofmaneuverability of the surgical instrument includes controllabledeformation of the shaft that is mediated by at least one of atemperature profile, a pressure profile, an electrical circuitry, amagnetic profile, an acoustic wave profile or an electro-magneticradiation profile.
 11. The surgical instrument of claim 1, wherein theflexually deformable and steerable shaft being controllably deformableto permit a high degree of maneuverability of the surgical instrumentincludes maneuverability and steerability of the surgical instrumentaround anatomical corners or difficult-to-reach anatomical body partsthat are normally inaccessible on a straight trajectory.
 12. Thesurgical instrument of claim 1, wherein the flexually deformable andsteerable shaft being controllably deformable to permit a high degree ofmaneuverability of the surgical instrument includes bending the shaft inreal time to navigate within a body space.
 13. The surgical instrumentof claim 1, wherein the flexually deformable and steerable shaft returnsto an original shape or configuration for easy removal of the surgicalinstrument from a body.
 14. The surgical instrument of claim 1, furthercomprising at least one data-transmission device.
 15. The surgicalinstrument of claim 14, wherein the at least one data-transmissiondevice is operably coupled to the image-acquisition device.
 16. Thesurgical instrument of claim 1, further comprising at least oneproximity detector disposed in the at least one grasping jaw or locatedin proximity to the at least one grasping jaw.
 17. The surgicalinstrument of claim 16, wherein the proximity detector is adapted todetect whether a biological tissue is partly within grasping distance ofthe grasping jaw.
 18. The surgical instrument of claim 16, wherein theproximity detector is adapted to detect whether a biological tissue isfully within grasping distance of the grasping jaw.
 19. The surgicalinstrument of claim 16, wherein the proximity detector is operablycoupled to at least one data-transmission device.
 20. The surgicalinstrument of claim 16, wherein the proximity detector includes anelectromagnetic energy emitter or an electromagnetic energy receiver.21. The surgical instrument of claim 16, wherein the proximity detectorincludes an acoustic energy emitter or an acoustic energy receiver. 22.The surgical instrument of claim 16, wherein the proximity detectorincludes a point source emitter or a source illuminator.
 23. Thesurgical instrument of claim 22, wherein the point source emitter orsource illuminator includes at least one of an ultrasonic source,acoustic source, visible source, ultraviolet source, gamma ray source,X-ray source, or infrared source.
 24. The surgical instrument of claim16, wherein the proximity detector includes a communication medium forcommunication with at least one image display.
 25. The surgicalinstrument of claim 16, wherein the proximity detector includes at leastone image-transmission device.
 26. The surgical instrument of claim 16,wherein the proximity detector is wirelessly coupled to at least oneimage display.
 27. The surgical instrument of claim 1, furthercomprising at least one grasping jaw that is fully redeployablefollowing at least one grasp-and-release cycle in a grasping operationof a biological tissue or bodily organ.